Description
Product Overview TheraPEAK® Nucleofector® Consumables are aimed to support the use of the 4D-Nucleofector® LV Unit as manufacturing equipment in a GMP manufacturing process for advanced therapeutic medicinal products (ATMPs). In such a process, the 4D-Nucleofector® LV Unit and its consumables may be used for non-viral, electroporation-based genetic modification of primary cells, for example T cells or hematopoietic stem cells. Like their research-grade counterparts, TheraPEAK® LV Nucleocuvette® Cartridges are the reaction vessels in which the electroporation process takes place. They are used in combination with TheraPEAK® Nucleofector® Solutions and TheraPEAK® 4D-Nucleofector® LV Reservoirs . Sterile welding: The PVC tubing extension which is attached to the silicone tubing allows for sterile welding to a TheraPEAK® Nucleofector® LV Reservoir or a bag. Alternatively sterile connections can be established manually via a Spinning Spiros connector. TheraPEAK® LV Nucleocuvette® Cartridges are tested for • Endotoxin (Ph. Eur. 2.6.14) • Cytotoxicity (EN ISO 10993-5:2009) • Visible particles (Ph. Eur. 2.9.20) • Sub-visible particles (Ph. Eur. 2.9.19) • Biology (Nucleofection) • Extractables (during validation) Disclaimer: TheraPEAK® Nucleofector® Products are produced according to applicable GMP standards and are intended to support GMP manufacturing. TheraPEAK® Nucleofector® Cartridges and Reservoirs are produced at manufacturing sites with an ISO13485 certified quality management system. TheraPEAK® Nucleofector® Products are not intended for in vivo and/or diagnostic purposes. Request More Info
Benefits Single-use consumables Use of biocompatible material, medical grade (where available) Produced at an ISO13485:2016 certified site in a class C environment Sterilized by ethylene oxide (validated process) Double-layer packaging supporting the clean room cascade Validated manufacturing and testing methods Applications Supporting use of 4D-Nucleofector® LV Unit in GMP manufacturing
Storage and Content 5 TheraPEAK® LV Nucleocuvette® Cartridges, weldable tubing
